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Wednesday, September 19, 2012

Roche v. Cipla: Section 8 Violation

I have posted
a few posts
on the Roche-Cipla
decision, but my analysis is far from complete. In the mean time, I wish to
draw the attention of the blog’s readers to a crisp and incisive analysis of
the decision undertaken by Ms.Shwetasree Majumder (“Shwe” to her friends), founding
partner of Fidus Law Chambers on Bar
and Bench. I strongly recommend a reading of this analysis, especially by those who may
not have the time or the patience needed to go through the 275-page judgment.

The specific portion of her piece which I think is particularly noteworthy is the one on Section 8 of
the Patents Act, which I intend to discuss in this post. I thank Shwetasree for sharing
her thoughts with me on the issue.

The ground of Section 8 is
discussed in the decision from Para 127 onwards. In Paras 153, 154 and 156
(Pages 133 and 134), following are the observations of the Learned Single Judge of the Delhi High Court:

“153. When the defendant has raised this
challenge in the counter claim and also filed the documents to that effect that
there is an application which was made in US in 2000 as US‘221 containing a
nexus between the previous compound and the Polymorphic B version of the same
and also has read in consonance with the stand which is preferred by the
plaintiffs now that both the versions are of the same nature and non grant of
one in India is inconsequential, The defendant is able to discharge the onus
which lied on him to show that there was an obligation to disclose.

Thereafter, it was upon the plaintiff to
displace the onus and justify as to how the said disclosure was not required or
the said disclosure was actually made. The
responses which are coming forth from the plaintiffs for filing of Form-3 twice
in 1996 and 2006 nowhere relates to foreign application and does not satisfy as
to how the disclosure was properly made of the developments which happened in
the year 2000. The fact that the Controller incidentally dealt with such
application filed in US‘221 while testing the opposition with the third party
does not absolve the responsibility of the plaintiffs as applicant for patent
to disclose the said information before the Controller which could have
impacted the decision making of the Controller.

154. Likewise, the stand of the plaintiffs
that both the inventions are different also seems unjustifiable in the light of
their present stand before this Court and no other response has been made
except what has been discussed above in detail by the plaintiffs. In view of
the same and also the requirements of Section 8 discussed above, it cannot be
said that the plaintiffs have been able to displace the said onus casted upon
them as to why the disclosure was not made as per the requirement of Section 8
of the Act. It appears at this stage
from the attending circumstances that the disclosure was not made and the said
Section was in fact violated by the patentee and therefore the ground contained
in Section 64(1)(m) is made out.”

Therefore,
from the underscored portions above, it is clear that the Learned Single Judge
was of the opinion that Roche had violated Section 8 of the Act. What is the
law on this point?

As
Shwetasree points out in her article, the law on violation of Section 8 has
been laid down by a Division Bench of the Delhi High Court (Justice Muralidhar)
in Chemtura Corporation v. Union of
India as follows:

“45. It is not
possible to accept the submission, made by referring to the Halsbury’s
Laws of England, that since the omission to furnish particulars is not serious enough to affect the grant
of the patent, it did not impinge on its validity. Section 64 (1) (j) and (m)
indicate to the contrary. Further under Section 43 (1) (b) a patent can be
granted only when the application has been found not to be contrary to any provision
of the Act. It cannot be said that the omission to comply with the requirement
of Section 8 (2) was not serious enough to affect the decision of the
Controller to grant the patent to the Plaintiff.

The information, if
provided, would have enlightened the Controller of the objections raised by the
US patent office and the extent to which the Plaintiff had to limit its claims
to the torus shape of the compression spring, which was a key feature of the
subject device. Had the Controller been informed of the Plaintiff’s
own patent No.3932005 dated 13th January 1976, he would have been called upon
to examine if that patent taught the use of a toroidal shape of a compression
member and whether therefore the subject device was an inventive step within
the meaning of the
Act.”

In Chemtura,the DB went on to vacate the interim injunction granted to the patentee on grounds that the Patentee had prima facieviolated the provisions of Section 8 of the Act. Considering the strict
interpretation of Section 8 followed by the DB, it is surprising that the Learned Single Judge in Roche v. Cipla does not refer to Chemtura although he is bound by the
judgment of the DB. Instead, the Single Judge goes on to hold thus in relation to the patentee, OSI Pharma’s violation of Section 8:

“156. Consequently, the ground of violation
of Section 8 read with Section 64(1)(m) is made out. However, still there lies a discretion to revoke or not to revoke
which I have discussed later under the head of relief. Under these
circumstances, even in case, the said compliance of Section 64(1)(m) of the Act
has not been made by the plaintiffs, still there lies a discretion in the Court
not to revoke the patent on the peculiar facts and circumstances of the present
case. The said discretion exists by use of the word ―may‖ under
Section 64 of the Act. Thus, solely on one ground of non-compliance of Section
8 of the Act by the plaintiffs, the suit patent cannot be revoked.”

All this verbiage boils down to one question- Does the Court or the IPAB
have the discretion to not revoke a patent when violation of Section 8 has been
clearly made out and acknowledged by it?

3 comments:

Good one Sai. I could never find a good reasoning behind inclusion of the section 8 ground for revocation and perhaps also for post-grant opposition. Isn’t it that the section 8 requirements are merely for the ease of the Controller – to reduce its efforts of finding out prior art documents and making its own opinion of patentability (in practical sense, to completely eliminate the efforts, as they rarely make any extra efforts to find out any new document or to make their own opinion), which it is supposed to do even otherwise (particularly when the relevant laws on patentability varies among jurisdictions). Isn’t it that the need of such information or documents would be over by the time the patent is granted? Isn’t it too trivial a ground to reject a granted patent, particularly when the Examiner has in fact on its own referred to the objections in other countries (which it always does) even though they were not specifically informed/provided by the Applicant.Coming to the practicality of this aspect, it is almost next to impossible or at least I have not come across any file at the Patent Office, where the requirement of section 8(1) have been strictly complied to by the Applicant (keeping in mind the deadline of 6 months from the date of filing the corresponding foreign application). This is a ritual objection in the FER and is supposedly complied with by the applicant to the satisfaction of the Examiner by providing details with a consolidated petition for condonation of delay under Rule 137. So if the Examiner has no issues with it and has cleared it, providing this ground (which is solely for the comfort and benefit of the Controller to its satisfaction) to the third parties is simply providing a tool of harassment in their hands.

More so, when the patents act doesn’t give a warranty of validity of a patent, which can always be challenged at any point of time on the grounds of novelty and inventiveness, why to stretch the burden so much on the Applicant/Patentee of disclosing the corresponding applications so as to be made them available as even a ground of rejecting a granted patent?

All this sounds too funny to me unless I am missing something. Could you help Sai?

Dear Ashwani,Thanks for your detailed comment. I think the reply to the comment merits an independent post. I will be shortly putting up another post as a follow up to this one. Hopefully, I would have answered your questions in that post.